HypovolemiaNCT00435422
Neuroaxial Blokade and Blood Pressure
A study testing Stroke volume optimization in people with Hypovolemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The effect of individualized fluid optimization during neuroaxial blockade has not been evaluated. The investigators evaluated if if Stroke decrease 15 min after activation of neuroaxial blockade and whether SV could be optimized to pre activation values. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Stroke volume optimization
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neuroaxial blockade (thoracic)
Who cannot join
- Weight below 40 kg
- Lithium therapy
- Type I diabetes or type II requiring insulin
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Morten Bundgaard-Nielsen, MD
Hans-Jørgen B Frederiksen, MD
About this study
Official title: Neuroaxial Blokade and the Effect of Fluid Optimization
The effect of individualized fluid optimization during neuroaxial blockade has not been evaluated. The investigators evaluated if if Stroke decrease 15 min after activation of neuroaxial blockade and whether SV could be optimized to pre activation values.
Read the detailed description
The purpose of this study is to evaluate SV maximization with aid of the LiDCO system which is a minimal invasive technique only requiring a venous and arterial line. We thereby attempt to cover the specific individual fluid deficit induced by neuroaxial blockade.
- Conditions
- Hypovolemia
- Being tested
- Stroke volume optimization
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke volume optimizationProcedure or surgery
Stroke volume optimization
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume
Measured: 15 min after blockade
Secondary outcomes (1)
Brain oxygenation, cardiac output, TPR, NIRS, BP
Measured: 15 min after blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startJan 2010
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Morten Bundgaard-Nielsen, MD, Principal investigator, Section of surgical pathophysiologyMorten Bundgaard-Nielsen, MD, Principal investigator, unafiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435422
- Sponsor's protocol ID
- Neuroaxial blokade and BP
- Status last verified
- Feb 2009
- First submitted
- 14 Feb 2007
- Last updated
- 25 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroaxial Blokade and the Effect of Fluid Optimization
- ClinicalTrials.gov ID
- NCT00435422
- Acronym / sponsor ID
- Neuroaxial blokade and BP
- Conditions
- Hypovolemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of individualized fluid optimization during neuroaxial blockade has not been evaluated. The investigators evaluated if if Stroke decrease 15 min after activation of neuroaxial blockade and whether SV could be optimized to pre activation values.
Detailed description
The purpose of this study is to evaluate SV maximization with aid of the LiDCO system which is a minimal invasive technique only requiring a venous and arterial line. We thereby attempt to cover the specific individual fluid deficit induced by neuroaxial blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neuroaxial blockade (thoracic)
Key exclusion criteria (3 listed)
- Weight below 40 kg
- Lithium therapy
- Type I diabetes or type II requiring insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke volume optimizationStroke volume optimization | Procedure or surgery | – |
Primary outcome
Stroke volume
Time frame: 15 min after blockade
1 secondary outcome
Brain oxygenation, cardiac output, TPR, NIRS, BP
Time frame: 15 min after blockade
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Bundgaard-Nielsen, MD principal investigator
Section of surgical pathophysiology
Morten Bundgaard-Nielsen, MD principal investigator
unafiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke volume optimization in people with Hypovolemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Bundgaard-Nielsen, MD (0045 35 45 09 55, morten.bundgaard-nielsen@rh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume (time frame: 15 min after blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2010.